(153 days)
The TRUE2go Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes. Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing. Not for neonatal use.
Not Found
The provided document is a 510(k) FDA clearance letter for the TRUE2go Blood Glucose Monitoring System, and it does not contain the detailed study information needed to answer all aspects of your request. This type of letter confirms the device's substantial equivalence to a predicate device but typically does not include the full study report with explicit acceptance criteria, detailed sample sizes, expert qualifications, or ground truth establishment methods in the way you've outlined for an AI/CAD device.
Blood glucose monitoring systems are generally evaluated based on accuracy against a laboratory reference method, and the acceptance criteria are usually defined by standards like ISO 15197 for in vitro diagnostic medical devices. However, this specific document doesn't provide those details.
Therefore, I cannot provide a complete answer based only on the provided text. I will answer what is inferable from the document and explicitly state what information is missing.
Here's a breakdown of what I can answer and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in this document. For blood glucose meters, these typically relate to the accuracy of readings compared to a laboratory reference method (e.g., specific percentages of readings falling within +/- X mg/dL or +/- Y% of the reference).
- Reported Device Performance: Not explicitly stated in this document. The document confirms market clearance based on substantial equivalence, implying performance met regulatory expectations for blood glucose meters, but specific metrics (e.g., mean absolute relative difference, percentage of readings within certain error margins) are not provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This question is more relevant for diagnostic imaging AI/CAD systems where expert radiologists establish ground truth. For a blood glucose meter, the "ground truth" is typically established by parallel measurements with a highly accurate laboratory reference instrument, not by human expert interpretation. The document does not describe the specific laboratory reference method or setup.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This is not applicable to a blood glucose monitoring system in the same way it would be for an AI/CAD system relying on expert interpretation. The "adjudication" in this context would be the comparison against the reference method, not a consensus among human interpreters.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not done. This type of study is specific to AI/CAD systems that assist human readers (e.g., radiologists, pathologists). The TRUE2go Blood Glucose Monitoring System is a standalone diagnostic device for quantitative glucose measurement, not an AI assistance tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done. The TRUE2go Blood Glucose Monitoring System is a standalone device. Its performance is measured by its accuracy in providing a glucose reading. The document doesn't detail the specific study, but a standalone performance evaluation against a reference method is fundamental for such a device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for a blood glucose monitor is typically derived from highly accurate laboratory reference methods (e.g., a YSI glucose analyzer or a hexokinase method performed on venous blood plasma/serum). This document does not specify the exact method used.
8. The sample size for the training set
- Not specified in this document. For a physical device like a blood glucose meter, the concept of a "training set" in the context of machine learning (where this question usually applies) isn't directly relevant in the same way. Performance is typically evaluated through clinical studies.
9. How the ground truth for the training set was established
- As above, the concept of a "training set" for a blood glucose meter isn't typically discussed in this context. Device calibration and validation against reference methods are standard, but the document does not detail these processes.
Summary of what is available from the document:
- Device Name: TRUE2go Blood Glucose Monitoring System
- Intended Use: Quantitative determination of glucose in human whole blood (fingerstick or forearm for home use; venous whole blood for healthcare professionals).
- Regulatory Status: Cleared via 510(k) as substantially equivalent to a predicate device.
- Not for neonatal use.
- The device is a standalone diagnostic system, not an AI/CAD system designed to assist human readers.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.